Effect of a substance P antagonist on aldosterone secretion in patients with obstructive sleep apnea and hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of a substance P antagonist, Aprepitant, on aldosterone secretion in patients suffering from obstructive sleep apnea syndrome (OSAS) and arterial hypertension. The study aims to understand the relationship between hyperaldosteronism and cardiovascular complications in these patients, particularly focusing on how obesity and metabolic syndrome may influence aldosterone levels. Participants will be randomly assigned to receive either the active drug or a placebo, with careful monitoring of their blood pressure and sleep apnea symptoms throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject with severe obstructive sleep apnea syndrome (OSAS) defined by an apnea and hypopnea index (AHI) ≥ 30/h on polysomnography or ventilatory polygraphy (requiring continuous positive airway pressure).
2. Subject with essential hypertension treated medically or by lifestyle and dietary measures or newly diagnosed (defined by SBP ≥ 140 and/or DBP ≥ 90 mmHg according to current SFHTA-HAS recommendations).
3. Patient's agreement to replace diuretics with another neutral antihypertensive treatment (which does not interfere with the renin-angiotensin system), to stop consuming licorice and its derivatives, 7 to 10 days before taking the treatment. experimental and throughout the study (if applicable)

Exclusion Criteria:

1. Minor subject or subject aged over 75 years
2. Criteria relating to associated pathologies leading to particular risks:

   * Subject presenting excessive daytime sleepiness with contraindication to driving (Epworth score \> 16)
   * Uncontrolled severe cardiovascular disease: myocardial infarction or stroke in the last 6 months, unstable angina, significant valvular heart disease, heart failure (≥ class II of the NYHA classification), uncontrolled cardiac arrhythmia or significant conduction abnormalities. Knowledge of chronic renal insufficiency defined by a glomerular filtration rate \< 60 mL/min/1.73m2 for more than 3 months) or moderate hepatic insufficiency defined by ALT and/or AST transaminases \> 3N)
   * Epilepsy
   * Known acute infections linked to HIV, HBV or HCV
   * Active cancer currently being treated
3. Contraindications to placebo and aprepitant

Where it's running

• CHU de Rouen
  Rouen, France, France Recruiting

Study contacts

• Study coordinator: Antoine-Guy Lopez
• Email: Antoine-Guy.Lopez@chu-rouen.fr
• Phone: 02 32 88 90 81

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.